Sulfamethoxazole and Trimethoprim

Product NDC: 33261-396
11-digit product format: 332610396
Labeler code: 33261
Product ID: 33261-396_a3ab3a35-a130-4804-9ad8-0d733c7a8d48
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfamethoxazole and Trimethoprim
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA076899
Marketing category: ANDA
Marketing start: 2010-02-25
Marketing end: 0000-00-00
Substance: SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength: 400 mg/1; mg/1
Pharmacologic classes: Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 12 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	33261-396		I	Inactivated by FDA	2026-08-11
excluded package	package	33261-396	33261-396-00	I	Inactivated by FDA	2026-08-11
excluded package	package	33261-396	33261-396-02	I	Inactivated by FDA	2026-08-11
excluded package	package	33261-396	33261-396-06	I	Inactivated by FDA	2026-08-11
excluded package	package	33261-396	33261-396-10	I	Inactivated by FDA	2026-08-11
excluded package	package	33261-396	33261-396-14	I	Inactivated by FDA	2026-08-11
excluded package	package	33261-396	33261-396-20	I	Inactivated by FDA	2026-08-11
excluded package	package	33261-396	33261-396-28	I	Inactivated by FDA	2026-08-11
excluded package	package	33261-396	33261-396-30	I	Inactivated by FDA	2026-08-11
excluded package	package	33261-396	33261-396-40	I	Inactivated by FDA	2026-08-11
excluded package	package	33261-396	33261-396-60	I	Inactivated by FDA	2026-08-11
excluded package	package	33261-396	33261-396-90	I	Inactivated by FDA	2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 5 · 252 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-396-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-396-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-396-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-396-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-396-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-396-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-396-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-396-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-396-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-396-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-396-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-396-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-396-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-396-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-396-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-396-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-396-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-396-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-396-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-396-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-396-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-396-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-396-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-396-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-396-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-396-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-396-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-396-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-396-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-396-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-396-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-396-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-396-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-396-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-396-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-396-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-396-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-396-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-396-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-396-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-396-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-396-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-396-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-396-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-396-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-396-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-396-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-396-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-396-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-396-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-396-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-396-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-396-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-396-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-396-06	`cfe11265f3b6…`	`090c488252e2…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB		2005-01-27
A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB		2005-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076899-001	AB
A076899-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076899-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076899-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076899-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076899-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076899-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076899-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076899-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076899-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076899-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076899-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076899-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076899-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076899-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076899-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076899-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076899-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076899-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076899-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076899-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076899-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076899-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076899-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076899-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076899-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076899-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076899-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076899-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076899-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076899-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076899-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076899-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076899-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076899-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076899-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076899-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076899-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076899-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076899-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076899-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076899-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ce811b5-329e-27f8-b5ff-66d52b435c00	Product name	3	20240108
8d30c4f0-0228-cea4-e3aa-f19064c47f27	Product name	3	20221128
6e20c430-5e8f-85da-1b03-f7dbc0c51fad	Product name	3	20190926
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
33261-396-00	Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-02	Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-06	Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-10	Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-14	Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-20	Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-28	Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-30	Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-40	Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-60	Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-90	Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33261-396-00	Sulfamethoxazole and Trimethoprim	100 in 1 BOTTLE	TABLET	100	1
33261-396-02	Sulfamethoxazole and Trimethoprim	120 in 1 BOTTLE	TABLET	120	1
33261-396-06	Sulfamethoxazole and Trimethoprim	6 in 1 BOTTLE	TABLET	6	1
33261-396-10	Sulfamethoxazole and Trimethoprim	10 in 1 BOTTLE	TABLET	10	1
33261-396-14	Sulfamethoxazole and Trimethoprim	14 in 1 BOTTLE	TABLET	14	1
33261-396-20	Sulfamethoxazole and Trimethoprim	20 in 1 BOTTLE	TABLET	20	1
33261-396-28	Sulfamethoxazole and Trimethoprim	28 in 1 BOTTLE	TABLET	28	1
33261-396-30	Sulfamethoxazole and Trimethoprim	30 in 1 BOTTLE	TABLET	30	1
33261-396-40	Sulfamethoxazole and Trimethoprim	40 in 1 BOTTLE	TABLET	40	1
33261-396-60	Sulfamethoxazole and Trimethoprim	60 in 1 BOTTLE	TABLET	60	1
33261-396-90	Sulfamethoxazole and Trimethoprim	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-396-14	EA - Each	33261-396	8e8363c7-55ed-4a6b-9cd6-e430950b4c90	1	2015-10-02
33261-396-30	EA - Each	33261-396	a7885881-cccb-4416-8d13-fbb93df3b647	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SULFAMETHOXAZOLE	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TRIMETHOPRIM	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SULFAMETHOXAZOLE	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-396	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 11 package rows	20121013_fb9d264a-0536-4517-84f1-2ea2f57658fe.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Amneal Pharmaceuticals LLC	f0e73842-6002-43c2-97fc-0cadc1bf6346	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	AvKARE	9f130443-c8e7-9122-8f27-f72f07f3f29e	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Northwind Health Company, LLC	f2b8e9d9-1274-22ca-e053-2a95a90a6f1a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Cardinal Health 107, LLC	5dc03027-cdaf-461f-87fd-630d382fc723	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Major Pharmaceuticals	abe0d2d5-4879-4b4e-9b57-47ea83a17ba0	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	0aaf1dbe-b69d-43bd-a4ab-69cb27ab417d	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Amneal Pharmaceuticals of New York LLC	3233c54d-484d-4550-b172-db8af47d1b7f	2025-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim DS	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Advanced Rx Pharmacy of Tennessee, LLC	b001e648-2710-3ada-e053-2995a90a52f1	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Bryant Ranch Prepack	a174991a-53e7-c791-3cee-b706a48e0ec5	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	f39a4c93-0a0e-4801-aecc-c55a2fa5e68b	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	ffc5d594-429c-4303-b3b6-f5a83e915b55	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	07a49665-fe2a-4a92-a57e-49db224b012e	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	8661e318-ddf3-4a60-8781-6fa42307c60a	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	b85a58a7-74d6-4629-8027-0cdcbb5c815a	2023-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	07da67b1-b50c-4471-8cde-8a119eb8c935	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethox-TMP DS	SULFAMETHOXAZOLE, TRIMETHOPRIM	PharmPak, Inc.	ede74118-32c5-4f52-9823-509538e674c8	2022-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Proficient Rx LP	0df74ba1-1aa6-467c-92e7-6b017c7c6bce	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JE42381TNV	SULFAMETHOXAZOLE	723-46-6	SULFAMETHOXAZOLE
AN164J8Y0X	TRIMETHOPRIM	738-70-5	TRIMETHOPRIM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	PSN	fb9d264a-0536-4517-84f1-2ea2f57658fe	1
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	SCD	fb9d264a-0536-4517-84f1-2ea2f57658fe	1
198334	SMX 400 MG / TMP 80 MG Oral Tablet	SY	fb9d264a-0536-4517-84f1-2ea2f57658fe	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-396-00	33261039600	100 in 1 BOTTLE	Historical
33261-396-02	33261039602	120 in 1 BOTTLE	Historical
33261-396-06	33261039606	6 in 1 BOTTLE	Historical
33261-396-10	33261039610	10 in 1 BOTTLE	Historical
33261-396-14	33261039614	14 in 1 BOTTLE	Historical
33261-396-20	33261039620	20 in 1 BOTTLE	Historical
33261-396-28	33261039628	28 in 1 BOTTLE	Historical
33261-396-30	33261039630	30 in 1 BOTTLE	Historical
33261-396-40	33261039640	40 in 1 BOTTLE	Historical
33261-396-60	33261039660	60 in 1 BOTTLE	Historical
33261-396-90	33261039690	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets	Aidarex Pharmaceuticals LLC	2012-10-12	HUMAN PRESCRIPTION DRUG LABEL	1